Setting boundaries

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued draft guidance for companies that operate consumer websites aimed at a UK audience and that provide services which might lead to the prescription and supply of prescription-only medicines (POMs).

The guidance is intended to assist companies promote their services without falling foul of the prohibition on advertising POMs to consumers. It is aimed primarily at companies and organisations that do not hold marketing authorisations for medicines, but do provide services which could lead to the prescription or supply of POMs (such as medical clinics or online pharmacies). It does not cover websites directed to healthcare professionals.

Pharmaceutical company websites remain subject to the ABPI Code of Practice, as updated earlier this year. This was referred to in the August 2008 issue of Pharmaceutical Marketing, in the article entitled 'By the book' in which Heather Simmonds of the PMCPA clarified what pharmaceutical companies can and can't do when marketing POMs online. This article looks instead at the MHRA guidance on websites, and the MHRA's disease awareness guidelines as set out in its Blue Guide.

Although the website guidance is not aimed principally at pharmaceutical companies, pharma should be aware of it and the disease awareness guidelines, as both documents provide useful guidance for any UK websites (or sections of such websites) directed at consumers, for which pharma companies are responsible.

Applicable websites The guidance covers all websites aimed at consumers "registered in the UK or aimed at the UK audience". Although there is no elaboration on what is meant by "registered in the UK" or "aimed at the UK audience", it is likely that this refers to:• Any website with a .co.uk address or other UK specific domain name • Any website that is clearly aimed at the UK market (eg, where it specifically offers delivery of goods or provision of services in the UK).

The MHRA's Blue Guide similarly states that "material posted on UK websites and/or aimed at the UK audience is subject to UK medicines advertising legislation".

Key pointsAs might be expected, much of the guidance is regarding how information should be provided to consumers, as set out in the disease awareness guidelines in the MHRA's Blue Guide. It is permissible to provide general information on a particular disease or condition on a consumer website, but any information on POMs must be balanced and presented only in the context of an overview of all the licensed treatment options. The website must not draw attention to specific medicines only, and must not encourage individuals to request a particular treatment. Medicines that are not licensed in the UK should not be mentioned at all.

The guidance stresses that the homepages of appropriate websites should not refer to named POMs, but should rather focus on the services they provide and, more generally, on any relevant medical conditions. A balanced overview of all licensed treatment options may be presented on a page within the website that the consumer navigates to.

When the website is for a clinic that offers a medical consultation to consumers, the guidance states it must be clear that the consumer is simply being offered a consultation and this may, or may not, lead to a prescription being given.

Websites must not include any features or slogans encouraging the purchase of POMs, and must not make any promotional claims in relation to POMs. In addition, they must not provide information on the cost of specific POMs. It is, however, permissible to provide indicative costs of a consultation and course of treatment.

Non-compliant sitesIf the MHRA considers that a failure to comply with the guidelines amounts to a breach of the relevant advertising regulations (the Medicines [Advertising] Regulations 1994), they will require the website to be amended or withdrawn. A failure to comply with the advertising regulations may also give rise to criminal liability.

Disease awareness The MHRA's guidelines on disease awareness (the guidelines) form Annex 3 of the Blue Guide. The guidelines address the contents of disease awareness campaigns and, in particular, the steps that should be taken to reduce the possibility of the campaign breaching the advertising of POMs to consumers prohibitions. This needs to be balanced against the requirement that the public has access to reliable and up-to-date information promoting awareness about health, diseases and their management. Indeed, this requirement is at the heart the European Commission's proposals regarding a relaxation of the prohibition on advertising POMs to consumers.

The primary purpose of disease awareness campaigns must be to increase awareness of a particular disease, or provide health information about a disease or its management. Such campaigns should not aim to stimulate demand for a particular medicine and should not promote the use of a particular medicinal product. The emphasis of disease awareness campaigns must be on the relevant disease and its recognition, rather than on its treatment options. The main objective of such campaigns, according to the guidelines, is to "encourage people to take appropriate steps, which may include seeking advice from appropriate healthcare professionals".

The guidelines set out seven key principles that information in disease awareness campaigns should conform to:• Accuracy – the public must not be misled by the information• Up to date – the information must be current and the publication date of the disease awareness campaigns must be clear• Substantiable – the information must be made substantiable by references to authoritative sources such as medical literature• Comprehensive – the information provided must cover all key characteristics of the disease• Balanced and fair – the implications of the disease should be conveyed in a realistic, non-alarmist manner and all management options must be fair and balanced • Readable – the language used should be clear and formatted in a user-friendly design• Identification of source – the source of the campaign must be clear.

The guidelines note that particular care should be taken in relation to disease awareness campaigns where there is only a single or one leading or a few products licensed to treat the relevant disease.

Campaigns in such cases are more likely to draw attention to a particular medicinal product, regardless of whether or not the product is referred to.

Relaxation of prohibition It is interesting to note that the MHRA issued its guidance at a time when the European Commission is considering a relaxation on the prohibitions surrounding advertising POMs to consumers; a proposal that has provoked a considerable response. The MHRA guidance aims to ensure POMs are not promoted to consumers through specific non-pharma routes, effectively reinforcing the prohibition on direct-to-consumer POMs advertising.

Pharmaceutical companies wishing to provide information for consumers through their websites should consider carefully the relevant provisions of the ABPI Code of Practice, as discussed by Heather Simmonds in her August 2008 article. However, all other firms operating relevant UK websites – such as online pharmacies or clinics offering medical services – should ensure that any content relating to POMs is balanced, accurate and non-promotional in nature, and should pay particular attention to the MHRA guidance on websites and the guidelines on disease awareness in the Blue Guide.